Hi All,

Yes, I believe that the ambiguity of GMP’s make it difficult for start-up companies that do not have pre-existing GMPs; however I do not believe it simply sets them up for failure. The ambiguity of the GMPs allow for them to setup their company the way they would like, without having to worry they follow each individual standard. While the ambiguity might seem to make the process difficult, it gives them a framework to base their quality system.

-Andrew Nashed